Contraindications - Spinal Kinetics M6-C Mode D'emploi

Contraindications

The M6 cervical disc should not be implanted in patients with the following conditions:
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Require an implant at 2 or more levels.
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Be ≥70 years of age.
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Have a bone mineral density with T-score ≤-1.5 as determined by spine DXA if male ≥60 years
of age or female ≥50 years of age.
•
Have an active systemic infection or infection at the operative site.
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Have sustained an osteoporotic fracture of the spine, hip or wrist.
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Have received medications (e.g., methotrexate, alendronate) that interfere with bone and
mineral metabolism within 2 weeks of the planned date of the index surgery.
•
Have any medical or surgical condition precluding the potential benefit of spinal surgery.
•
Have a history of endocrine or metabolic disorders (e.g., Paget's disease) known to affect bone
and mineral metabolism.
•
Have rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV
or active hepatitis.
•
Have spinal metastases.
•
Have a known allergy to titanium, polyurethane, polyethylene or ethylene oxide residuals.
•
Have type 1 or type 2 diabetes requiring daily insulin management.
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Be pregnant.
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Have axial neck pain as the solitary symptom.
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Have severe cervical myelopathy as evidenced by any sign of gait disturbance, unilateral or bilateral
leg weakness, and/or uncontrollable bowel/bladder symptoms related to cervical spine disease.
•
Require a treatment (e.g., posterior element decompression) that destabilizes the spine.
•
Have advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the
operative site.
•
Have clinically compromised vertebral body structure (unhealed fracture) at any cervical level due
to acute or past trauma.
•
Have pharmaceutical, alcohol or other substance abuse.
•
Have instability shown by angulation of the disc space more than 11 degrees greater than adjacent
segments.
•
Have a BMI above 30.
•
Have advanced degenerative changes (e.g., spondylosis) at the index vertebral level as evidenced by:
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Bridging osteophytes;
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Average ROM <4º;
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Disc height <25% of the AP width of the inferior vertebral body; as measured in a lateral
radiograph in neutral position;
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Subluxation >3mm;
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Kyphotic deformity at >20º on neutral radiographs.
Precautions
•
Read and understand the M6 cervical disc System Instructions for Use prior to use.
•
The M6 artificial cervical disc is intended to be used with the M6 artificial cervical disc Instruments.
Refer to the M6 artificial cervical disc Surgical Technique Manual for implantation instructions.
•
The M6 cervical disc System is intended to be used only by surgeons with training in cervical
spine surgery and related surgical techniques, and biomechanical principles of the spine and
spine arthroplasty.
•
Prior to use, the surgeon must be trained in the surgical procedure as outlined in the M6 artificial
cervical disc Surgical Technique Manual and thoroughly familiar with the implant and instruments.
•
Improper surgical use and technique may lead to suboptimal clinical outcomes.
•
Do not use the M6 cervical disc after the last day of the month of the "Use by date" on the label.
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